MX2018003705A - Metodos para producir formulaciones de glucagon terapeuticas estables en solventes polares aproticos. - Google Patents
Metodos para producir formulaciones de glucagon terapeuticas estables en solventes polares aproticos.Info
- Publication number
- MX2018003705A MX2018003705A MX2018003705A MX2018003705A MX2018003705A MX 2018003705 A MX2018003705 A MX 2018003705A MX 2018003705 A MX2018003705 A MX 2018003705A MX 2018003705 A MX2018003705 A MX 2018003705A MX 2018003705 A MX2018003705 A MX 2018003705A
- Authority
- MX
- Mexico
- Prior art keywords
- aprotic polar
- methods
- polar solvents
- producing stable
- stable therapeutic
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 239000002798 polar solvent Substances 0.000 title abstract 2
- 102000051325 Glucagon Human genes 0.000 title 1
- 108060003199 Glucagon Proteins 0.000 title 1
- MASNOZXLGMXCHN-ZLPAWPGGSA-N glucagon Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C1=CC=CC=C1 MASNOZXLGMXCHN-ZLPAWPGGSA-N 0.000 title 1
- 229960004666 glucagon Drugs 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 230000001225 therapeutic effect Effects 0.000 title 1
- 239000003814 drug Substances 0.000 abstract 3
- 229940124597 therapeutic agent Drugs 0.000 abstract 3
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 230000000087 stabilizing effect Effects 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/26—Glucagons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A—HUMAN NECESSITIES
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Ciertas modalidades se dirigen a una formulación de un agente terapéutico, así como un método para hacer tal formulación, que comprende al menos un agente terapéutico disuelto en un sistema de solvente polar aprótico que comprende al menos un excipiente estabilizante de ionización en una concentración suficiente para impartir estabilidad física y química al agente terapéutico.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562233032P | 2015-09-25 | 2015-09-25 | |
US15/136,650 US9649364B2 (en) | 2015-09-25 | 2016-04-22 | Methods for producing stable therapeutic formulations in aprotic polar solvents |
PCT/US2016/053628 WO2017053922A1 (en) | 2015-09-25 | 2016-09-25 | Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2018003705A true MX2018003705A (es) | 2018-06-06 |
Family
ID=57113760
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2018003705A MX2018003705A (es) | 2015-09-25 | 2016-09-25 | Metodos para producir formulaciones de glucagon terapeuticas estables en solventes polares aproticos. |
Country Status (17)
Country | Link |
---|---|
US (5) | US9649364B2 (es) |
EP (2) | EP3352780B1 (es) |
JP (1) | JP6835831B2 (es) |
KR (2) | KR20240056643A (es) |
CN (2) | CN115531523A (es) |
AU (1) | AU2016326749B2 (es) |
BR (1) | BR112018005800A2 (es) |
CA (2) | CA3204984A1 (es) |
DK (1) | DK3352780T3 (es) |
EA (1) | EA201890704A1 (es) |
ES (1) | ES2970863T3 (es) |
HK (1) | HK1250644A1 (es) |
IL (1) | IL258298B (es) |
MX (1) | MX2018003705A (es) |
SA (1) | SA518391187B1 (es) |
WO (1) | WO2017053922A1 (es) |
ZA (2) | ZA201801912B (es) |
Families Citing this family (12)
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US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
US20160074515A1 (en) | 2014-06-20 | 2016-03-17 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
US20200147306A1 (en) | 2017-07-14 | 2020-05-14 | Xeris Pharmaceuticals, Inc. | Methods for treating congenital hyperinsulinism |
WO2019126753A1 (en) * | 2017-12-22 | 2019-06-27 | Xeris Pharmaceuticals, Inc. | Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes |
US20210030847A1 (en) * | 2018-01-23 | 2021-02-04 | Xeris Pharmaceuticals, Inc. | Treatment of post-bariatric hypoglycemia using mini-dose stable glucagon |
KR102493469B1 (ko) * | 2018-03-07 | 2023-02-07 | 코메라 라이프 사이언시스, 인코포레이티드 | 단백질 제형을 위한 부형제 화합물 |
CN118105340A (zh) | 2019-05-31 | 2024-05-31 | Xeris药物公司 | 非质子极性溶剂中的稳定治疗组合物及其制造方法 |
CN112807281A (zh) * | 2019-10-31 | 2021-05-18 | 南京海维医药科技有限公司 | 包含血管紧张素ii的稳定组合物及其制备方法、使用方法 |
IL299337A (en) * | 2020-06-26 | 2023-02-01 | Xeris Pharmaceuticals Inc | Pharmaceutical compounds with stable sustained release in polar aprotic solvents and methods of making them |
US20240148678A1 (en) | 2022-10-19 | 2024-05-09 | Xeris Pharmaceuticals, Inc. | Sustained release injectable therapeutic formulations using aprotic polar solvents |
US20240148680A1 (en) | 2022-10-19 | 2024-05-09 | Xeris Pharmaceuticals, Inc. | Stable levothyroxine compositions in aprotic polar solvents |
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